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02/09 Rina Arun
Team Leader at United HR Solutions Pvt. Ltd.

Views:129 Applications:1 Rec. Actions:Recruiter Actions:1

Officer - Regulatory Affairs - Medical Device (7-10 yrs)

Ahmedabad/Gujarat Job Code: 29231

Position : Regulatory Affairs Officer

Qualification : Pharmacist, Bachelor/Master in Pharmacy or Pharmaceutical Science.

Work experience : 7-10 years- experience in regulatory affairs from reputed Medical Device organization.

- Experience in handling African countries is a requirement and other Asian/Latin region desirable. Experience with medical devices would be preferable candidate for the position.

Competences :

- Regulatory knowledge in handling pharmaceutical products as well as medical devices.

- Superior expertise in medical device regulations and reporting in different countries.

- Prepared and submitted Technical file applications with supporting documentation to qualify for CE marking certificate registration.

- Should possess adequate knowledge on MDD or MDR regulations and applicable standards.

- Reviewed medical device labelling and advertising materials for accuracy and completeness.

- Compiled and reviewed medical device registration data for different class of products.

- Experience of preparation and submission of CTD in different countries for ROW market.

- Experience in handling queries received from NDRA in compliance to regulatory requirement.

- Updated on various regulatory guidelines on WHO, EU, ICH and ISO standards.

- Should be energetic and passionate about work.

- Ability to maintain positive attitude when under pressure and in stressful situations.

- Good administrative skills.

- Experience in project management.

- Team player with good communication skills.

- Should be well structured and systematic.

Languages : Proficiency in English is required.

Duties/Responsibilities :

- Responsible for coordination with supplier for arranging documents timely for dossier compilation.

- Concurrent follow-up with Country Manager, Agent and NDRA for ongoing submissions.

- Responsible for preparation, review and dispatch of registration dossiers for pharmaceutical products and medical devices as per application guidelines.

- Responsible for samples dispatch and to provide information to CM and agents.

- Review of registration dossiers for Medical Devices products with labelling requirement.

- Ensure all activities related to Regulatory Affairs (RA) complies with SOPs and regulatory / customer requirements.

- Responsible for evaluation, response preparation with supporting documents from supplier to query received from NDRA within deadlines.

- Coordination with cross-functional dept. on regulatory assistance.

- Review of product layouts (labels, leaflets, SPCs) in line with regulatory guidelines pharmaceutical products and medical devices.

- Proactive and dedicated work on product registration ensuring meeting deadlines.

- To support activities within team and collaborate on the development of strategies, execution of projects and ad hoc tasks.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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